Раствор для инфузий и подкожного введения "Ронколейкин" 3 ампулы по 1 мл (0,5 мг) является иммуностимулятором и обладает противогрибковой, противоопухолевой, противовирусной и противобактериальной активностью. Рекомбинантный интерлейкин-2 (рИЛ-2), структурный и функциональный аналог эндогенного интерлейкина-2 (ИЛ-2). ИЛ-2 продуцируется субпопуляцией Т-лимфоцитов (Т-хелперы I) в ответ на антигенную стимуляцию. Синтезированный ИЛ-2 воздействуетнаТ-лимфоциты, усиливая их пролиферацию и последующий синтез ИЛ-2. Биологические эффекты ИЛ-2 опосредуются его связыванием со специфическими рецепторами, представленными на различных клеточных мишенях. ИЛ-2 направленно влияет на рост, дифференцировку и активацию Т- и В-лимфоцитов, моноцитов, макрофагов, олигодендроглиальных клеток, клеток Лангерганса. От его присутствия зависит развитие цитолитической активности натуральных киллеров и цитотоксических Т-лимфоцитов. ИЛ-2 вызывает образование лимфокинактивированных киллеров и активирует опухоль-инфильтрирующие клетки. Расширение спектра лизирующего действия эффекторных клеток обусловливает элиминацию разнообразных патогенных микроорганизмов, инфицированных и малигнизированных клеток, что обеспечивает иммунную защиту, направленную против опухолевых клеток, а также возбудителей вирусной, бактериальной и грибковой инфекции.
Показания к применению
В составе комплексной терапии у взрослых: обычный вариабельный иммунодефицит, комбинированный иммунодефицит, острый перитонит, острый панкреатит, остеомиелит, эндометрит, тяжелая пневмония, сепсис, послеродовый сепсис, туберкулез легких, другие генерализованные и тяжелые локализованные инфекции, инфицированные термические и химические ожоги, диссеминированные и местнораспространенные формы почечноклеточного рака. В составе комплексной терапии у детей от 0 лет: обычный вариабельный иммунодефицит, комбинированный иммунодефицит, острый перитонит, острый панкреатит, остеомиелит, тяжелая пневмония, бактериальный сепсис новорожденных, сепсис, другие генерализованные и тяжелые локализованные инфекции.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности.
Способ применения и дозы
Ронколейкин вводят 1 раз/сут п/к или в/в капельно по 0.5-1.0 мг с интервалами 1-3 дня, на курс - 1-3 введения. Для в/в введения препарат из ампулы переносят в 400 мл изотонического раствора натрия хлорида для инъекций. Инфузия всего объема раствора осуществляется капельно в течение 4-6 ч. Раствор препарата должен быть прозрачным, бесцветным и не содержать посторонних включений. Иммунотерапию препаратом Ронколейкин проводят после завершения неотложных и срочных оперативных вмешательств, направленных на устранение жизнеугрожающих последствий основного заболевания/травмы, санации и адекватного дренирования инфекционного очага. При лечении тяжелого сепсиса проводят от 1 до 3 курсов лечения препаратом Ронколейкин. Курс включает 2 в/в инфузии в дозе 0.5 мг через день. Критерием для назначения второго и третьего курсов лечения препаратом Ронколейкин является сохраняющаяся в ходе лечения лимфопения (абсолютная и/или относительная). При впервые выявленном инфильтративном деструктивном туберкулезе легких - 3 в/в инфузии препарата Ронколейкин в дозе 0.5 мг с интервалом 48 ч на фоне специфической полихимиотерапии. Для предоперационной подготовки при прогрессирующем фиброзно-кавернозном туберкулезе (ФКТ) легких на фоне специфической полихимиотерапии: при одностороннем ФКТ - 3 в/в введения препарата Ронколейкин по 1 мг с интервалом 48 ч, при распространенном ФКТ легких с двусторонней очаговой диссеминацией - 7 в/в введений препарата Ронколейкин: 3 введения в течение первой недели по 1 мг с интервалом 48 ч, далее по 1 мг 2 раза в неделю в течение 2 недель. Рекомендуемый курс иммунотерапии должен быть завершен за 7-10 дней до оперативного вмешательства. Назначение препарата Ронколейкин при туберкулезе легких нецелесообразно при дефиците массы тела более 30%. Курс лечения препаратом Ронколейкин диссеминированных и местнораспространенных форм почечно-клеточного рака включает:— однократное п/к или в/в введение препарата в дозе 0.5 мг за 24 ч до операции,— в составе 8-недельного курса иммунохимиотерапии по 2.0 мг в/в через день в течение первых 4 недель лечения. Повторные курсы проводят через 1-2 мес. У детей Ронколейкин применяют в/в капельно. Схемы применения соответствуют таковым у взрослых. Препарат разводят в изотоническом (0.9%) растворе натрия хлорида. Разовая доза препарата и объем изотонического раствора у детей зависит от возраста:— от 0 до 1 мес - 0.1 мг в 30-50 мл раствора,— от 1 мес до 1 года - 0.125 мг в 100 мл раствора,— от 1 года до 7 лет - 0.25 мг в 200 мл раствора,— старше 7 лет - 0.5 мг в 200 мл раствора,— старше 14 лет - 0.5 мг в 400 мл раствора.
Побочное действие
Системные реакции: в отдельных случаях возможно появление кратковременного озноба и повышение температуры тела в процессе введения препарата Ронколейкин, что купируется обычными терапевтическими средствами и не является основанием для прерывания введения препарата, а также отмены курса терапии. Местные реакции: при п/к введении препарата отмечались болезненность, уплотнение, покраснение в месте инъекции.
Передозировка
Симптомы передозировки наблюдались при приеме препарата Ронколейкин в разовой дозе выше 7 мг в виде лихорадки, нарушения ритма сердца, гипотонии, дерматологических аллергических реакций. Лечение: данные симптомы купируются после отмены введения препарата, при необходимости проводится симптоматическая терапия.
Особые указания
Противопоказания к применению: аутоиммунные заболевания, сердечная недостаточность III ст., легочно-сердечная недостаточность III ст., метастатическое поражение головного мозга, терминальная стадия почечно-клеточного рака, беременность, повышенная чувствительность к дрожжам, повышенная чувствительность к интерлейкину-2 или любому компоненту препарата в анамнезе. С осторожностью: при хронической почечной недостаточности, декомпенсированной печеночной недостаточности. Влияние на способность к вождению автотранспорта и управлению механизмами. Специальных исследований влияния препарата на способность управлять транспортными средствами и использовать сложное оборудование не проводилось. В случае развития нежелательных реакций со стороны органа зрения и/или снижения способности к концентрации внимания и быстроты реакции пациентам рекомендуется воздержаться от управления транспортными средствами или работы со сложным оборудованием до разрешения указанных нежелательных реакций.
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Рекомбинантный интерлейкин-2 (рИЛ-2), структурный и функциональный аналог эндогенного интерлейкина-2 (ИЛ-2). ИЛ-2 продуцируется субпопуляцией Т-лимфоцитов (Т-хелперы I) в ответ на антигенную стимуляцию. Синтезированный ИЛ-2 воздействуетнаТ-лимфоциты, усиливая их пролиферацию и последующий синтез ИЛ-2. Биологические эффекты ИЛ-2 опосредуются его связыванием со специфическими рецепторами, представленными на различных клеточных мишенях. ИЛ-2 направленно влияет на рост, дифференцировку и активацию Т- и В-лимфоцитов, моноцитов, макрофагов, олигодендроглиальных клеток, клеток Лангерганса. От его присутствия зависит развитие цитолитической активности натуральных киллеров и цитотоксических Т-лимфоцитов. ИЛ-2 вызывает образование лимфокинактивированных киллеров и активирует опухоль-инфильтрирующие клетки. Расширение спектра лизирующего действия эффекторных клеток обусловливает элиминацию разнообразных патогенных микроорганизмов, инфицированных и малигнизированных клеток, что обеспечивает иммунную защиту, направленную против опухолевых клеток, а также возбудителей вирусной, бактериальной и грибковой инфекции."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В составе комплексной терапии у взрослых: обычный вариабельный иммунодефицит, комбинированный иммунодефицит, острый перитонит, острый панкреатит, остеомиелит, эндометрит, тяжелая пневмония, сепсис, послеродовый сепсис, туберкулез легких, другие генерализованные и тяжелые локализованные инфекции, инфицированные термические и химические ожоги, диссеминированные и местнораспространенные формы почечноклеточного рака. В составе комплексной терапии у детей от 0 лет: обычный вариабельный иммунодефицит, комбинированный иммунодефицит, острый перитонит, острый панкреатит, остеомиелит, тяжелая пневмония, бактериальный сепсис новорожденных, сепсис, другие генерализованные и тяжелые локализованные инфекции."}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ронколейкин вводят 1 раз/сут п/к или в/в капельно по 0.5-1.0 мг с интервалами 1-3 дня, на курс - 1-3 введения. Для в/в введения препарат из ампулы переносят в 400 мл изотонического раствора натрия хлорида для инъекций. Инфузия всего объема раствора осуществляется капельно в течение 4-6 ч. Раствор препарата должен быть прозрачным, бесцветным и не содержать посторонних включений. Иммунотерапию препаратом Ронколейкин проводят после завершения неотложных и срочных оперативных вмешательств, направленных на устранение жизнеугрожающих последствий основного заболевания/травмы, санации и адекватного дренирования инфекционного очага. При лечении тяжелого сепсиса проводят от 1 до 3 курсов лечения препаратом Ронколейкин. Курс включает 2 в/в инфузии в дозе 0.5 мг через день. Критерием для назначения второго и третьего курсов лечения препаратом Ронколейкин является сохраняющаяся в ходе лечения лимфопения (абсолютная и/или относительная). При впервые выявленном инфильтративном деструктивном туберкулезе легких - 3 в/в инфузии препарата Ронколейкин в дозе 0.5 мг с интервалом 48 ч на фоне специфической полихимиотерапии. Для предоперационной подготовки при прогрессирующем фиброзно-кавернозном туберкулезе (ФКТ) легких на фоне специфической полихимиотерапии: при одностороннем ФКТ - 3 в/в введения препарата Ронколейкин по 1 мг с интервалом 48 ч, при распространенном ФКТ легких с двусторонней очаговой диссеминацией - 7 в/в введений препарата Ронколейкин: 3 введения в течение первой недели по 1 мг с интервалом 48 ч, далее по 1 мг 2 раза в неделю в течение 2 недель. Рекомендуемый курс иммунотерапии должен быть завершен за 7-10 дней до оперативного вмешательства. Назначение препарата Ронколейкин при туберкулезе легких нецелесообразно при дефиците массы тела более 30%. Курс лечения препаратом Ронколейкин диссеминированных и местнораспространенных форм почечно-клеточного рака включает:— однократное п/к или в/в введение препарата в дозе 0.5 мг за 24 ч до операции,— в составе 8-недельного курса иммунохимиотерапии по 2.0 мг в/в через день в течение первых 4 недель лечения. Повторные курсы проводят через 1-2 мес. У детей Ронколейкин применяют в/в капельно. Схемы применения соответствуют таковым у взрослых. Препарат разводят в изотоническом (0.9%) растворе натрия хлорида. Разовая доза препарата и объем изотонического раствора у детей зависит от возраста:— от 0 до 1 мес - 0.1 мг в 30-50 мл раствора,— от 1 мес до 1 года - 0.125 мг в 100 мл раствора,— от 1 года до 7 лет - 0.25 мг в 200 мл раствора,— старше 7 лет - 0.5 мг в 200 мл раствора,— старше 14 лет - 0.5 мг в 400 мл раствора."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Системные реакции: в отдельных случаях возможно появление кратковременного озноба и повышение температуры тела в процессе введения препарата Ронколейкин, что купируется обычными терапевтическими средствами и не является основанием для прерывания введения препарата, а также отмены курса терапии. Местные реакции: при п/к введении препарата отмечались болезненность, уплотнение, покраснение в месте инъекции."}}]},{"id":7,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы передозировки наблюдались при приеме препарата Ронколейкин в разовой дозе выше 7 мг в виде лихорадки, нарушения ритма сердца, гипотонии, дерматологических аллергических реакций. 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